Challenges in conducting a randomized clinical trial of older people with chronic dizziness: before, during and after vestibular rehabilitation

Abstract

Purpose: This study aims to describe the process of conducting a randomized clinical trial of elderly with chronic dizziness subjected to vestibular rehabilitation (VR) and to verify its effectiveness on dizziness intensity.

Methods: Older adults (≥65 years) with chronic dizziness from vestibular disorders referred to VR were enrolled to the trial. The control group (n=40) was submitted to the Cawthorne & Cooksey protocol and the experimental group (n=42) to the modified Cawthorne & Cooksey protocol which included multiple components. Protocols were performed during individual 50-minute sessions, twice-weekly, for eight weeks. Main measures were: recruitment data (refusal and eligibility), baseline characteristics, dropout rate, session attendance, protocol adherence, adverse effects, exercise adaptation and follow-up events. The Visual Analog Scale (VAS) was used to measure dizziness intensity.

Results: 144 elderly were referred to VR, 26.4% declined to participate and 16.7% were ineligible. There were 51 session non-attendances, with disease being the most frequent reason. Regardless of VR protocol, VAS dizziness intensity diminished along sessions (p<0.001). 88.6% of the participants reported improvement after treatment, and 22.9% mentioned an increase in dizziness on follow-up. Home exercises were no longer being performed by 21.4% of the subjects after 3 months from discharge. The final dropout rate was 14.6%. There were no differences between VR protocols on recruitment, dropout, session's attendance, adherence to protocol and treatment effects.

Conclusions: Our results revealed many challenges in conducting a rehabilitation trial with an elderly sample. The VR protocols showed to be feasible and suitable to reduce dizziness in older adults.

Keywords: Dizziness; Elderly; Patient adherence; Patient dropouts; Vestibular rehabilitation.